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    Summary
    EudraCT Number:2020-003733-38
    Sponsor's Protocol Code Number:ORP-TMZ-I-b
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-12-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-003733-38
    A.3Full title of the trial
    TEMOkids study (ORP-TMZ-I- b): A Population pharmacokinetic, acceptability and safety study for KIMOZO, a paediatric oral suspension of temozolomide
    Onderzoek naar de populatiefarmacokinetiek, aanvaardbaarheid en veiligheid van Kimozo, een pediatrische suspensie van temozolomide voor oraal gebruik (TEMOkids)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TEMOkids study: Study of the fate in the body, acceptability and safety study of KIMOZO, a drinkable form of temozolomide adapted to children
    TEMOkids studie: Onderzoek naar de farmacokinetiek, aanvaardbaarheid en veiligheid van Kimozo, een pediatrische suspensie van temozolomide voor oraal gebruik
    A.3.2Name or abbreviated title of the trial where available
    TEMOkids study
    TEMOkids studie
    A.4.1Sponsor's protocol code numberORP-TMZ-I-b
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorORPHELIA Pharma
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportORPHELIA Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationORPHELIA Pharma
    B.5.2Functional name of contact pointContact
    B.5.3 Address:
    B.5.3.1Street Address85 boulevard Saint Michel
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75005
    B.5.3.4CountryFrance
    B.5.4Telephone number33142770818
    B.5.6E-mailcontact@orphelia-pharma.eu
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/19/2188
    D.3 Description of the IMP
    D.3.1Product nameKIMOZO
    D.3.2Product code ORP-005
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTEMOZOLOMIDE
    D.3.9.1CAS number 85622-93-1
    D.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Different pediatric cancers such as malignant glioma and also relapsed or refractory neuroblastoma, rhabdomyosarcoma, medulloblastoma, and Ewing sarcoma, for which treatment with the cytotoxic temozolomide is recommended as per treatment guidelines.
    Diverse vormen van kanker bij kinderen, zoals maligne glioom, recidiverend of refractair neuroblastoom, rabdomyosarcoom, medulloblastoom en Ewing-sarcoom, waarvoor behandeling met het cytoxische geneesmiddel temozolomide wordt aanbevolen in hun therapeutische behandelingstrategie
    E.1.1.1Medical condition in easily understood language
    Different pediatric cancers for which treatment with the anticancer temozolomide is recommended as per treatment guidelines
    Diverse vormen van pediatrische kanker, waarvoor behandeling met het cytotoxische geneesmiddel temozolomide wordt aanbevolen.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018337
    E.1.2Term Glioblastoma multiforme
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029260
    E.1.2Term Neuroblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10039022
    E.1.2Term Rhabdomyosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027107
    E.1.2Term Medulloblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate PK parameters of the oral suspension of temozolomide (Kimozo) in the paediatric population aged 1 year and over.
    Evaluatie van de PK-parameters van de orale suspensie van temozolomide (Kimozo) bij de pediatrische populatie van 1 jaar en ouder.
    E.2.2Secondary objectives of the trial
    • Evaluate the safety of Kimozo, the oral suspension of temozolomide,
    • Evaluate the acceptability of Kimozo, the oral suspension of temozolomide.
    • Describe the activity of Kimozo, the oral suspension of temozolomide, over the course of a 6-month-treatment period (complete or partial response, disease progression, stable disease) according to the standard follow up exams and tests recommended for each indication

    • Evaluatie van de veiligheid van Kimozo, de suspensie van temozolomide voor oraal gebruik;
    • Evaluatie van de aanvaardbaarheid van Kimozo, de suspensie van temozolomide voor oraal gebruik;
    • Beschrijving van de activiteit van Kimozo, de suspensie van temozolomide voor oraal gebruik (complete of partiële respons, ziekteprogressie), gedurende een behandelperiode van 6 maanden op basis van de standaard follow-uponderzoeken en -testen die voor elke indicatie worden aanbevolen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Paediatric patients already receiving commercially available temozolomide-based treatment or naïve paediatric patients requiring temozolomide-based treatment as per investigator’s decision (all indications with 5-day treatment per 21- or 28-day cycle). Indications include those described in the Temodal SmPC (i.e. malignant glioma such as glioblastoma and anaplastic astrocytoma). For patients having no therapeutic alternatives, the IMP may be used in off-label indications in accordance with current treatment protocols recommended by European and International Medical Associations (e.g. SIOPEN, EPSSG, COG, European ITCC, SIOP,…). Such indications include but are not limited to primarily neuroblastoma, medulloblastoma and also rhabdomyosarcoma, or Ewing sarcoma
    • Male and female patients aged 1 to less than 18 years
    • Patients who have signed the informed consent or for which one, both parents or legal guardian (depending on local legislation) have signed the informed consent.
    • Patients having records of coverage by a health insurance
    • Life expectancy ≥ 3 months
    • Adequate haematological function:
    o haemoglobin ≥ 80 g/L (transfusion support authorized)
    o neutrophil count ≥ 1.0 x 109 cells/L
    o platelet count ≥ 100 x 109 cells/L (without transfusion support)
    o in case of bone marrow involvement: neutrophils ≥ 0.5 x 109 cells/L and platelets ≥75 x 109 cells/L
    • Adequate renal function:
    o Creatine clearance ≥ 60 mL/min.1.73m² according to the Schwartz formula [1] or its modified form [2]
    • Adequate hepatic function:
    o bilirubin ≤1.5 x ULN
    o AST and ALT ≤ 2.5 x ULN (AST, ALT 5xULN in case of liver metastases)
    • Lansky Score ≥ 70%
    • Pediatrische patiënten die reeds een commercieel beschikbare behandeling met temozolomide ondergaan of naïeve pediatrische patiënten die een behandeling met temozolomide nodig hebben volgens de beslissing van de onderzoeker (alle indicaties met een 5 dagen durende behandeling per cyclus van 21 of 28 dagen). De indicaties omvatten de indicaties die beschreven staan in de Temodal SmPC (d.w.z. maligne glioom zoals glioblastoom en anaplastisch astrocytoom). Voor patiënten zonder therapeutische alternatieven mag het IMP worden gebruikt in off-label indicaties overeenkomstig de huidige behandelprotocollen die worden aanbevolen door Europese en internationale medische verenigingen (zoals SIOPEN, EPSSG, COG, Europese ITCC, SIOP, ...). Dergelijke indicaties omvatten, maar zijn niet beperkt tot, primair neuroblastoom, medulloblastoom en ook rhabdomyosarcoom of Ewing-sarcoom.
    • Mannelijke en vrouwelijke patiënten met een leeftijd van 1 jaar en ouder en jonger dan 18 jaar
    • Patiënten die de geïnformeerde toestemming hebben ondertekend of voor wie beide ouders of de wettelijk voogd (afhankelijk van de lokale wetgeving), de geïnformeerde toestemming hebben ondertekend.
    • Patiënten die over een ziektekostenverzekering beschikken
    • Levensverwachting ≥ 3 maanden
    • Adequate hematologische functie:
    o Hemoglobine ≥ 80 g/L (transfusie-ondersteuning toegestaan)
    o Aantal neutrofielen ≥ 1.0 x 109 cellen/L
    o Aantal bloedplaatjes ≥ 100 x 109 cellen/L (zonder transfusie-ondersteuning)
    o Ingeval van betrokkenheid van beenmerg: neutrofielen ≥ 0,5 x 109 cellen/L en bloedplaatjes ≥ 75 x 109 cellen/L
    • Adequate nierfunctie:
    o Creatinineklaring ≥ 60 mL/min. 1,73m² volgens de Schwartz-formule of in zijn gewijzigde vorm
    • Adequate leverfunctie:
    o Bilirubine ≤1,5 x ULN
    o AST en ALT ≤ 2,5 x ULN (AST, ALT 5xULN ingeval van levermetastasen)
    • Lansky-score ≥ 70%
    E.4Principal exclusion criteria
    •Patient treated with sodium valproate within two weeks prior to receiving Kimozo or patients who are co-administrated on day one of Kimozo administration with sodium valproate as it decreases the clearance of temozolomide.
    • Patients with (naso)gastric tube administration of Kimozo .
    • Patients already enrolled in studies investigating temozolomide or other investigational new drugs.
    • A post-menarche female with a positive blood/urine pregnancy test at inclusion.
    • Known contraindication or hypersensitivity to temozolomide or any chemically close substance.
    • Persons who are living in a facility by order of a court or an administrative order.
    • Patients infected by a SARS-CoV-2 variant.
    • Patiënten die binnen twee weken voorafgaand aan de toediening van Kimozo met natriumvalproaat worden behandeld of patiënten die op de eerste dag van Kimozo-toediening worden toegediend met natriumvalproaat omdat dit de klaring van temozolomide vertraagt.
    • Patiënten bij wie Kimozo via een (neus)maagsonde zou moeten worden toegediend gedurende de eerste behandelcyclus.
    • Patiënten die reeds deelnemen aan onderzoeken naar temozolomide of andere nieuwe geneesmiddelen voor onderzoek.
    • Een postmenarche vrouwelijke patiënt met een positieve zwangerschapstest via bloed of urine op moment van inclusie
    • Bekende contra-indicatie of overgevoeligheid voor temozolomide of een andere chemisch gerelateerde substantie.
    • Personen die wonen in een instelling op bevel van een rechtbank of een administratieve beschikking.
    • Patiënten geïnfecteerd met een SARS-CoV-2-variant
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    Investigated PK parameters will be TMZ apparent clearance (CL/F), distribution volume (V/F) and absorption rate constant (Ka). These PK parameters will be used to derive key estimates of exposure such as TMZ area under the curve between 2 intakes (AUC0-t) and, if feasible, maximum concentration (Cmax) for each included subject and elimination half-life (t1/2), and the total AUC0-∞.
    Population PK parameters will be estimated by a population analysis performed with NONMEM (7.4). Individual Bayesian estimates of the PK parameters will be used to calculate individual AUC24, Cmax, and t1/2.
    Primaire uitkomstmaten:
    De PK-parameters die worden onderzocht, zijn de schijnbare klaring (CL/F), het schijnbare verdelingsvolume (V/F) en de schijnbare absorptiesnelheidsconstante (Ka) van TMZ. Deze PK-parameters worden gebruikt om er belangrijke schattingen van de blootstelling uit af te leiden, zoals het oppervlak onder de TMZ-plasmaconcentratie-tijdcurve tussen 2 toedieningen (AUC0-t), zo mogelijk de maximale TMZ-plasmaconcentratie (Cmax) voor elke in het onderzoek opgenomen patiënt en de TMZ-eliminatiehalfwaardetijd (t1/2) en de totale AUC0-∞.
    Populatiefarmacokinetische parameters worden geschat op grond van een populatiefarmacokinetische analyse die wordt uitgevoerd met het NONMEM-programma (7.4). Met betrekking tot de PK-parameters wordt er gebruik gemaakt van individuele Bayesiaanse schattingen om de individuele AUC24, Cmax en t1/2 te berekenen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A total of 6 blood samples of 1 ml* will be drawn per patient in a single daytime hospitalisation. Blood samples will be collected in prechilled K2-EDTA tubes prior to Kimozo administration and at 0.10-0.20 (6-12 min), 0.33-0.66 (20-40 min), 0.75-1.5 (45-90 min), 2.0-3.0 and 6.0-8.0 hours post-dose. The administered dose and exact time for each sample will be recorded. Should a patient be naïve to any prior treatment with TMZ, the pre-treatment sample is not necessary.
    *a minimum of 750 µL for blood sampling is required to collect 100 µL of plasma in duplicate
    Op dag 1, worden er in totaal 6 bloedmonsters van 1 ml* afgenomen per patiënt. Deze monsters worden voor toediening, en 0,10-0,20 uur (6-12 min), 0,33-0,66 uur (20-40 min), 0,75-1,5 uur (45-90 min), 2,0-3,0 uur en 6,0-8,0 uur na toediening van de dosis in vooraf gekoelde, K2-EDTA buisjes afgenomen. De toegediende dosis en het exacte afnametijdstip van elk monster worden vastgelegd. Mocht een patiënt nooit met TMZ behandeld wordt, dan is het voorbehandelingsmonster niet nodig.
    *voor 2 x 100 µl plasma moet er een monster van minimaal 750 µl bloed worden afgenomen
    E.5.2Secondary end point(s)
    Please enter information in English and add any other language that is applicableSecondary endpoints:
    • Acceptability
    The acceptability of Kimozo will be scored with a standardized assessment tool: CAST - ClinSearch Acceptability Score Test. This tool measures 9 observational drivers of medicine acceptability.
    • Safety
    All Safety events will be collected throughout the study, including buccal tolerance
    • Activity
    The clinical activity of Kimozo during the optional treatment extension phase will be described according to the standard follow-up exams and tests (i.e. complete or partial response, disease progression, stable disease)
    Secundair eindpunt
    Aanvaardbaarheid
    De aanvaardbaarheid van Kimozo wordt met een gestandaardiseerd beoordelingsinstrument gemeten: CAST - ClinSearch Acceptability Score Test®. Met dit instrument worden 9 observeerbare bepalende factoren van de aanvaardbaarheid van een geneesmiddel gemeten.

    Veiligheid
    Alle bijwerkingen, inclusief orale tolerantie, worden tijdens het onderzoek verzameld

    Activiteit
    De klinische activiteit van de suspensie van Kimozo tijdens de optionele behandelingsverlengingsfase zal worden beschreven op basis van de standaardfollow-uponderzoeken en -testen (d.w.z. complete of partiële respons, ziekteprogressie, stabiele ziekte)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Acceptability
    A paper diary will be filled-in to assess palatability/acceptability of Kimozo on the day of the first administration (day one first cycle) and on the day 5 of the first cycle
    • Safety
    Safety events will be recorded from the signature of the conscent form until the end of the study. When at hom, safety events will be recorded in the the patient diary and medically controlled on a monthly basis by the principal investigator.
    • Activity
    The clinical activity will be assessed on monthly basis at the end of each cycles.
    - Aanvaardbaarheid
    Een papieren dagboek zal worden ingevuld om de aanvaardbaarheid van Kimozo te beoordelen op de dag van de eerste toediening (dag één van de eerste cyclus) en op dag 5 van de eerste cyclus
    - Veiligheid
    Veiligheidsvoorvallen zullen worden geregistreerd vanaf de ondertekening van het conscentieformulier tot het einde van de studie. Bij thuisgebruik zullen Veiligheidsvoorvallen worden geregistreerd in het patiëntendagboek. Het zal maandelijks medisch worden gecontroleerd door de hoofdonderzoeker.
    - Activiteit
    De klinische activiteit zal maandelijks worden beoordeeld aan het einde van elke cyclus.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    population pharmacokinetic study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    paediatric patients from the age of 1 year to be included, thus incapable of giving consent personnally
    pediatrische patiënten vanaf 1 jaar die geen persoonlijke toestemming kunnen geven, zullen worden opgenomen
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Already included in the protocol, an optional treatment extension phase of up to 5 additional treatment cycles after the main study period made of 1 cycle of treatment with the oral suspension of the cytotoxic drug temozolomide
    Het protocol omvat een optionele behandelingsverlengingsfase tot 5 aanvullende cycli na de hoofdperiode (beperkt tot een behandelingscyclus met de orale suspensie van het cytotoxische geneesmiddel temozolomide) van het onderzoek.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-03
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